Rezlidhia (olutasidenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Metrics Contract Services. Rezlidhia (olutasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215814s000lbl.pdf. Revised December 2022. Accessed October 6, 2026.

View API

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. 5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) IDH1 p.R132C Acute Myeloid Leukemia Olutasidenib
FDA (1) IDH1 p.R132G Acute Myeloid Leukemia Olutasidenib
FDA (1) IDH1 p.R132H Acute Myeloid Leukemia Olutasidenib
FDA (1) IDH1 p.R132L Acute Myeloid Leukemia Olutasidenib
FDA (1) IDH1 p.R132S Acute Myeloid Leukemia Olutasidenib